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NMPA Announcement on Adopting ICH Guidelines S12
2023-09-05
To align the technical standards for drug registration with international standards, the NMPA has decided upon deliberation to adopt the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guidelines S12: Nonclinical Biodistribution Considerations for Gene Therapy Products(hereinafter referred to as S12).
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NMPA Announcement on Adopting ICH Guidelines Q12
2023-08-25
To align the technical standards for drug registration with international standards, the NMPA has decided to adopt the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) Guidelines Q12: Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management.
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Sunvozertinib Tablets Approved for Marketing by China NMPA
2023-08-23
Recently, the Category 1 innovative drug Sunvozertinib Tablets (Chinese trade name: 舒沃哲) of Dizal (Jiangsu) Pharmaceutical Co., Ltd is approved by China NMPA.
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Tafolecimab Injection Approved for Marketing by China NMPA
2023-08-16
Recently, the Tafolecimab Injection (trade name: SINTBILO®) of Innovent Biologics (Suzhou) Co., Ltd. is approved by China NMPA.
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TCM Compound Preparation Pipa Qingfei Granules Approved for Marketing by China NMPA
2023-07-27
Recently, another traditional Chinese medicine (TCM) compound preparation Pipa Qingfei granules regulated as one of the ancient classic formulae (which is a category 3.1 innovative TCM) is approved for marketing through technical evaluation.
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Shenge Bushen Capsule Approved for Marketing by China NMPA
2022-12-29
Recently, the Category 1.1 innovative traditional Chinese medicine (TCM) Shenge Bushen Capsule of Xinjiang Huachun Biological Pharmaceutical Co., Ltd was approved for marketing by China NMPA.
